Onconova Therapeutics Announces Enrollment in Second Cohort of Phase 1 Study with ON 123300 in China
01 April 2021 - 11:00PM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a
clinical-stage biopharmaceutical company focused on discovering and
developing novel products for patients with cancer, announces that
its corporate partner HanX Biopharmaceuticals has enrolled three
patients in the second dosing cohort of its Phase 1 study with ON
123300 in HR+ HER2- metastatic breast cancer and other advanced
relapsed/refractory cancers in China.
The HanX trial has enrolled six patients to date
in two cohorts and may continue to enroll patients with advanced
relapsed/refractory cancer at increasing doses with three to six
patients per dose until the recommended Phase 2 dose is
identified. To date, patients have been dosed at the 40
mg and 80 mg dosage levels. HanX recently opened a third site, in
Shanghai, for the conduct of the study.
“We are encouraged that the HanX Phase 1 study
is proceeding as planned, and look forward to the identification of
a recommended Phase 2 dose to move into later-stage trials. The
third cohort in this trial with 120 mg of ON 123300 is expected to
begin enrollment next; depending on the incidence of dose limiting
toxicities, if any, at the 80 mg cohort,” said Steven M. Fruchtman,
M.D., President and Chief Executive Officer of Onconova
Therapeutics. “The HanX study trial design calls for dosing on days
1-21 of each 28-day cycle, compared with our planned Phase 1 study
in the U.S. that will assess the safety, tolerability and
pharmacokinetics of ON 123300 administered orally as monotherapy at
increasing doses starting at 40 mg daily for continuous 28-day
cycles. We are preparing to begin our U.S. study in the second
quarter of 2021.”
“ON 123300 is a multi-kinase inhibitor in
addition to targeting CDK 4/6, which we believe presents an
innovative approach to treating advanced cancers including HR+
HER2- metastatic breast cancer that is, or has become, resistant to
commercial CDK 4/6 inhibitors. Beyond metastatic breast cancer, we
believe ON 123300 may present an innovative approach to treating
other cancers including mantle cell lymphoma, multiple myeloma,
advanced colorectal cancer, hepatocellular carcinoma and inoperable
glioblastoma,” concluded Dr. Fruchtman.
In December 2017, Onconova entered into an
agreement with HanX Biopharmaceuticals for the development,
registration, and commercialization of ON 123300 in Greater China.
The agreement included a licensing fee, future potential milestone
payments, and royalties on sales. Onconova retains rights to ON
123300 in the rest of the world outside of Greater China.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage
biopharmaceutical company focused on discovering and developing
novel products for patients with cancer. The Company has
proprietary targeted anti-cancer agents designed to disrupt
specific cellular pathways that are important for cancer cell
proliferation.
Onconova’s novel, proprietary multi-kinase
inhibitor ON 123300 is planned to begin a dose-escalation and
expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation
and expansion Phase 1 trial is currently underway in China.
Onconova’s product candidate oral rigosertib is
currently in a dose-escalation and expansion Phase 1
investigator-initiated study targeting patients with KRAS+ lung
adenocarcinoma in combination with nivolumab. In addition, Onconova
continues to conduct preclinical work investigating rigosertib in
COVID-19.
For more information, please visit
www.onconova.com.
Forward-Looking Statements
Some of the statements in this release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, and involve risks and uncertainties.
These statements relate to Onconova’s expectations regarding the
registered direct offering, its patents and clinical development
plans including patient enrollment timelines and indications for
its product candidates. Onconova has attempted to identify
forward-looking statements by terminology including "believes,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should," "approximately" or other words
that convey uncertainty of future events or outcomes. Although
Onconova believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements.
These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including the success and
timing of Onconova's clinical trials and regulatory agency and
institutional review board approvals of protocols, Onconova’s
ability to continue as a going concern, the need for additional
financing, Onconova’s collaborations, market conditions and those
discussed under the heading "Risk Factors" in Onconova's most
recent Annual Report on Form 10-K and quarterly reports on Form
10-Q. Any forward-looking statements contained in this release
speak only as of its date. Onconova undertakes no obligation to
update any forward-looking statements contained in this release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
Company Contact:Avi OlerOnconova Therapeutics,
Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
Investor Contact:LHA Investor Relations Kim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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